Ultrasound Guided Transversus Abdominis Plane(TAP) Block in Intensive Care Unit

Colon Neoplasm Clinical Trial

Official title:

Ultrasound Guided Transversus Abdominis Plane(TAP) Block in Intensive Care Unit(ICU) for Postoperative Analgesia After Open Colon Resection: a Double Blind Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03198338
• Other study ID #: B1706-401-001
• Status: Recruiting
• Phase: N/A
• First received: June 20, 2017
• Last updated: June 23, 2017
• Start date: July 1, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: June 2017
• Source: Seoul National University Bundang Hospital
• Contact: Tak Kyu Oh, M.D.
• Phone: 82-10-2602-5950
• Email: airohtak[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Transversus Abdominis Block (TAP) block is known to be an effective means of reducing patient pain after abdominal surgery. In the meantime, the general TAP block has been studied in patients who were in the recovery room and the ward after surgery. The purpose of this study was to determine the effect of pain reduction and opioid saving effects in patients with TAP block in ICU settings.

Description:

This study is a prospective study in a single institute of Seoul National University Bundang Hospital and is assigned to the test group and the control group by random assignment. In both groups, PCA (Patient Controlled Analgesia) was used as a post-operative pain control modality. In the Intervention group, a 0.25% Bupivacaine was used for transverse nerve block , and normal saline was used for placebo(control) group

The TAP block will be performed within 1 hour after entering the intensive care unit (ICU) in double blinded state

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Adults over 20 years of age

• Patients who entered the intensive care unit for monitoring and recovery after colonic resection through laparotomy

• Patients who voluntarily sign a written informed consent and know they have the right to withdraw their consent at any time.

Exclusion Criteria:

• Patients who are unconscious and require sedation below the Richmond Agitation Sedation Scale (-2) Patients who need continuous renal replacement therapy, cardiopulmonary bypass Patients with a history of allergic reactions to local anesthetics Patients resistant to narcotic analgesics (users of existing long-term narcotic analgesics) Patients who can not use self-analgesic treatment Patients who underwent surgery for organs other than abdomen and pelvis Patients with severe blood clotting disorders with a Prothrombin Time International normalized ratio of 2.0 or greater and Platelet less than 50,000

Related Conditions & MeSH terms

• Colon Neoplasm
• Colonic Neoplasms
• Intestinal Perforation
• Neoplasms
• Perforated Bowel
• Perforated Colon
• Rectal Neoplasms
• Rectum Neoplasm

Intervention

Drug:
• 0.25% Bupivacaine, 0.5mL/kg
Ultrasound guided TAP block using 0.25% Bupivacaine, 0.5ml/kg
• Normal Saline
0.9% Normal Saline

Device:
• Ultrasound
Ultrasound guided TAP block

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain department	Seongnam-si	Gyeong gi do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Niraj G, Kelkar A, Fox AJ. Application of the transversus abdominis plane block in the intensive care unit. Anaesth Intensive Care. 2009 Jul;37(4):650-2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	opioid consumption up to 24 hours	The total amount of IV Fentanyl (10mcg/cc) used by the patients for 24 hours. Patient Controlled Analgesia will be used.	24hour after TAP block
Secondary	resting pain score	resting Numeric Rating Scale, 0-10, 0= no pain, 10= most severe pain	2hour, 6hour, 12hour, 24hour after TAP block
Secondary	Nausea score	Nausea score, 0=none, 1=nausea symptom, 2- nausea requiring treatment, 3=vomiting	2hour, 6hour, 12hour, 24hour after TAP block
Secondary	sedation score	0- awake, 1- mild sedation, easy to rouse, 1s= asleep, easy to rouse, 2-moderate sedation, unable to remain awake, 3- difficult to rouse	2hour, 6hour, 12hour, 24hour after TAP block